The Performance of Dexcom G6 Glucose Monitoring in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean absolute relative difference (MARD)
研究概览
简要总结
This is an investigator-initiated, prospective, observational accuracy-study. The aim of the study is to test the feasibility, safety, and accuracy of a subcutaneous continuous glucose monitoring system (the Dexcom G6 glucose monitoring system) in critically ill patients. A total of 40 adult patients admitted to the intensive care unit requiring intravenous insulin infusion to maintain blood glucose within target range will be enrolled. Subcutaneous glucose readings will be compared with routine arterial blood glucose measurements to determine accuracy.
详细描述
The primary endpoint of the study is the mean absolute relative difference (MARD) in percent between CGM and arterial glucose values. Calculations show that 40 patients are required for a 95% confidence interval for the mean to have a range of ±1.7%, meaning that MARD can be estimated with high precision. Calculations of confidence intervals were done using normal approximation, assuming an SD of 5.5 percentage units.
The following variables will be collected from the electronic medical record (Take Care), from the ICU-specific patient data management system (Clinisoft) and/or from the handheld Dexcom G6 monitor:
Patient-related variables:
- Age, sex, height and weight
- Comorbidities (including diabetes status)
- Chronic medications
Clinical variables:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Admitted to ICU at the Karolinska University Hospital Solna
- •Indwelling arterial catheter in situ or expected to be inserted in the next 2 hours
- •Six hours or less since intravenous insulin infusion was commenced or intravenous insulin infusion expected to commence within the next 2 hours
- •Vasopressor infusion ongoing or expected to commence within the next 2 hours
- •Mechanical ventilation ongoing or expected to commence within the next 2 hours
- •Patient expected to stay in the ICU until the day after tomorrow
排除标准
- •Pregnancy
- •Unable to get consent from patient or next-of-kin
- •Patients in whom death is considered imminent (within 24 hours)
结局指标
主要结局
Mean absolute relative difference (MARD)
时间窗: From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days
MARD in percent between subcutaneous sensor glucose values and arterial blood glucose values
次要结局
- Correlation(From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days)
- Mean absolute difference (MAD)(From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days)
- Numerical accuracy according to ISO criteria(From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days)
- Numerical accuracy according to CLSI standard(From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days)
- Clinical accuracy determined by surveillance error grid analysis(From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days)
- Clinical accuracy determined by Clarke error grid analysis(From date of sensor insertion until date of ICU discharge, date of removal of the arterial line, or date of death, whichever came first, assessed up to 10 days)
研究者
Johan Mårtensson
Associate Professor
Region Stockholm